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Study of MK8669 in Patients With Solid Tumors (8669-003)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00694083
First received: May 29, 2008
Last updated: July 7, 2011
Last verified: July 2011
History of Changes

May 29, 2008
July 7, 2011
June 2008
September 2009   (final data collection date for primary outcome measure)
Any clinical or laboratory adverse experience. [ Time Frame: Duration of Treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00694083 on ClinicalTrials.gov Archive Site
Pharmacokinetics [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of MK8669 in Patients With Solid Tumors (8669-003)(COMPLETED)
A Phase I Study of MK8669 in Patients With Metastatic or Locally Advanced Solid Tumors

A clinical study evaluates the safety, tolerability, and pharmacokinetics of MK8669 in patients with locally advanced or metastatic solid tumors.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasm
Drug: MK8669
MK8669 (20 or 40 mg) Oral, QD x5 (five consecutive days followed by two days holiday)for 4 consecutive weeks.
Experimental: 1
Study medication
Intervention: Drug: MK8669
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically - Or Cytologically- Confirmed Metastatic Or Locally Advanced Solid Tumors That Has Failed To Respond To Standard Therapy, Or For Which Adequate Standard Therapy Dose Not Exist
  • ECOG Performance Status 0 or 1
  • Adequate Organ Function

Exclusion Criteria:

  • Patient Who Has Had Chemotherapy, Radiotherapy, Or Biological Therapy Within 4 Weeks (6 Weeks For Nitrosoureas Or Mitomycin C) Prior To Registration
  • Any CNS Metastasis Which Has Symptom Or Requires Treatment
  • Any Primary Central Nervous System Tumor
  • Any Symptomatic Ascites Or Plural Effusion Which Requires Treatment
  • A History Or Current Evidence Of Any Clinically Significant Disease That Might Confound The Results Of The Study, Complicate The Interpretation Of The Study Results, Interfere With The Patient'S Participation, Or Pose An Additional Risk To The Patient
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00694083
2008_011, MK8669-003
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP